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Clinical Specialist (multiple location in Europe)
The Clinical Specialist (CS) will serve as a cross functional customer focused single point of contact to provide detailed support to investigational treatment site teams participating in clinical trials or administering chimeric antigen receptor (CAR) T cell products in the EU. The CS will work with the GCRD and Global Trial Management/Monitoring (GTMM) teams as well as Medical Affairs and Commercial Teams to provide scientific and medical input into CAR T projects. This includes training and education as well as problem solving in the conduct and operations of clinical trials.
• The CS will serve as a single-point-of-contact for product & process related questions at CART treatment sites in an effort to ensure process consistency and compliance from study start up onwards. An ability to identify, prevent, and solve logistical issues that would delay or prevent study site activation and individual subject treatment is critical. The CS becomes a product, protocol and project subject matter expert to support internal and external customers. Extensive travel to EU investigational sites for CAR T programs is mandatory and essential.
Responsibilities will include, but are not limited to, the following:
1. Coordinate site and country level interactions for clinical trials with CAR T cells with GCRD, GTMM, CROs, Translational Development, Regulatory, Medical Affairs, and Commercial teams.
2. Prevention of, and response to, issues during enrollment and conduct of clinical trials.
3. Develop subject matter expertise in CAR T cell therapy and management of adverse events and clinical trials of CAR T cells.
4. Accelerate site activation and recruitment.
5. Develop internal and external training materials
6. Provide internal and external guidance and training on implementation of CAR T cell therapies
7. Support with site qualification and training for Aphaeresis procedure
8. Develop working knowledge of ATMPs and related regional/local regulations
9. Develop a site specific CAR-T network, ensuring multi-disciplinary participation and coordination of patient management
The CS will serve as a “bridge” for the treatment sites to ensure process consistency and support from clinical development phase through post-approval commercialization phase.
• Work with CRAs, GTMM and clinical trial sites to coordinate on-boarding activities:
o Training of all key stakeholders at treatment site (e.g., pharmacy, physicians, nursing staff and ICU)
o Facilitate customized hospital ordering and logistics, processes in an effort to ensure consistent cell logistics outcomes
o Coordinate mock shipment with Cell Lab (as needed)
o Demonstrate the patient allocation / manufacturing sign-up process
o Ensure product tracking and timely access to appropriate Celgene resources
o Provide on-site support to answer questions and ensure appropriate support from subject matter experts
o Support appropriate education of referring physicians (e.g., appropriate patients, apheresis timing)
o Ensure ready access to rescue medicines (e.g., anti-cytokine therapies) are available
• Regularly share treatment site experience and challenges with appropriate Celgene functions and develop custom solutions as needed
• Facilitate the compliant approval and on-boarding of new CAR T treatment centers:
o Conduct site capabilities, perform process assessment and confirm site certification
o Facilitate training of apheresis staff to perform apheresis and provide quality starting manufacturing material
o Support ordering, logistics, and communication processes as needed
o Ensure consistent, timely delivery of CART products
o Connect treatment site with appropriate Celgene subject matter experts to address “just-in-time” needs
o Actively participate in regular scheduling/logistics meetings to review cell status, logistics, etc.
• Train and interact with Celgene Medical Affairs and Commercial teams to shape future commercialization plans
• Support long term follow-up studies for patients enrolled on clinical trials of CAR T cells and commercial use
Undergraduate degree in life sciences required. Advanced degree in the life sciences (e.g. PharmD, NP, PA, RN) preferred.
Prior customer- facing role in pharmaceutical industry also preferred
Working knowledge and experience in the treatment of hematologic malignancies including acute leukemias, non-Hodgkins lymphoma, and multiple myeloma
Allogeneic stem cell transplant or apheresis experience preferred
Extensive medical/scientific and clinical research knowledge
Ability to rapidly solve problems and deal with organizational complexity
Knowledge of Medical Terminology
Knowledge of clinical trial design, basic statistics, pharmacodynamics and pharmacokinetics
Knowledge of GCP and ICH Guidelines
EU Travel required
Clinical project management skills
Proficient in Microsoft Word, Excel, PowerPoint; Microsoft project and JReview a plus
Demonstrated ability to work as part of a team
Ability to interface cross-functionally with clinical personnel.
High level of interpersonal and communication skills (written and verbal)
Prior experience as a medical monitor, clinical science or medical liaison, health care provider valuable
Interest in working with medical affairs and commercial teams
Demonstrated ability to network and build partnerships with important external customers
Strong leadership skills with a clear service orientation
Ability to assimilate technical and scientific information quickly